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Principal Investigator's Guide - Section 3

Regulatory Requirements, Representations and Certifications

Chapter I. Regulatory Requirements

Sponsors, in response to legislative initiatives concerned with issues of social and fiscal accountability, have attached a variety of regulatory requirements to government assistance programs which must be satisfied in advance of, or during, the conduct of a funded project. These requirements usually call for special review processes to ensure compliance with applicable federal, state and/or University regulations and the health and safety of those involved in the project, as attested to by the signature of the principal investigator (PI) and/or the University's authorizing official. The PI is responsible for obtaining the appropriate approvals when submitting proposals involving any of the following:

Human Subjects

In accordance with federal regulations, the University has an Assurance Agreement with the federal government, which describes University policies and procedures for the protection of human subjects in research. Under the terms of the Assurance, all proposals involving human subjects must be reviewed and approved by the University Committee on Activities Involving Human Subjects (UCAIHS), whether they are faculty- or student-directed and whether they are funded or unfunded. Such proposals must be accompanied by a completed "Application for Review by the University Committee on Activities Involving Human Subjects," including any applicable attachments and required number of "Application" copies. The "Application," as well as the Principal Investigator's Manual for Submitting Proposals for Review by the Human Subject Committee, may be obtained from OSP.

Before submitting an Application for Review, PIs must first take an On-line Human Subjects Tutorial. (In the case of student-directed proposals, the Faculty Advisor must also take the Tutorial.) When the prospective sponsor is the National Institutes of Health (NIH), the University must be able to certify that all key personnel named in the proposal, in addition to the PI, has completed and passed the Tutorial.

UCAIHS must approve all proposals for projects involving the use of human subjects before a funding agency will make an award. Researchers may not begin any such research project until final, written approval has been received from UCAIHS. In addition, throughout the period of the project, it is the PI's responsibility to supervise the conduct of any students or research assistants who are also working on the project, as well as to instruct them in the importance of safeguarding the welfare of human subjects. All researchers directing projects are expected to familiarize themselves with the regulations contained in the University's Assurance Agreement, a copy of which is available at OSP.

Laboratory Animals

The humane care and use of animals for research and/or teaching is the concern of the University Animal Welfare Committee (UAWC). All use of living vertebrates for these purposes is subject to the Committee's prior review and approval. To obtain approval, submit a Protocol Form to the school or departmental representative on the Committee indicating the species, number, procedures, and the care and housing of the animals intended for use in the project. This same information should also be provided in the proposal as instructed in sponsor guidelines. Review and approval of the protocol will be verified to the sponsor by OSP. An assigned protocol number is necessary for the acquisition of all laboratory animals, whether or not the activity will be externally funded.

In addition, all participants in research or instruction using animals must be certified by the UAWC through the Office of Veterinary Resources (OVR). Certification requires candidates to demonstrate that they are familiarwith applicable rules and guidelines and adequately trained in the appropriate conduct of animal research.

Radiation Safety

Possession and use of radioactive material at specific locations within NYU is permitted under licenses granted by New York City and administered by Dr. Christopher Marshall, Radiation Safety Officer, on behalf of the Radiation Safety Committee, whose activities are housed in the office of the Dean for Science. The Committee has established and oversees a program to ensure compliance with regulatory requirements which apply to the use of sources of ionizing radiation at Washington Square, including the Kriser Dental Center and the Institute of Fine Arts. PIs are individually responsible for notifying Charles Strom, Director, Chemical Labs, ext. 8-8480, for permit procedures and training of project personnel, when proposed activities will involve radioactive material.

Recombinant DNA

The 'NIH Guidelines for Research Involving Recombinant DNA Molecules' apply to all non-exempt recombinant DNA (rDNA) activities at NYU, including the creation, breeding, or use of transgenic rodents. The Guidelines, which are more accurately 'requirements' set forth principles and standards for safe and ethical conduct of recombinant DNA research, and apply to both basic and clinical research studies. The Institutional Biosafety Committee, housed at the NYU School of Medicine, is responsible for approving risk assessment and the biosafety containment levels for such experiments. In cases where proposals include this activity, PIs must register with the Committee using the standard form, downloadable from the SOM website.

For protocols that may require Biosafety Level 2 containment, PIs must first submit registration documents to the Washington Square Biosafety Officer, who will certify that all appropriate biological safety standards have been met as a condition for Committee approval. Submit such protocols to the attention of Paul Rubock, 740 Broadway, ext. 8-1440.

Environmental Health and Safety

Environmental Health & Safety (EHS) provides the University with comprehensive environmental health and safety services. Investigators using hazardous chemicals or biological materials are responsible for ensuring that their operations are consistent with applicable regulations and University policies. The EHS website provides information on the range of programs and services managed and conducted by the department.

Consult Paul Rubock, for assistance in identifying and evaluating operating and process hazards to ensure that research facilities are operating in a safe manner and comply with regulatory requirements.

Chapter II. Representations and Certifications

Sponsors often require applicant organizations to provide signed affirmation of compliance with a variety of federal, state, local and University policies, whether or not they may be directly applicable to the proposed project. Consult OSP whenever such form affirmations are required. Normally the following representations and certifications are included in application materials or incorporated by reference, and, unless otherwise noted, call only for the signature of the University's authorizing official:

Debt, Debarment, and Suspension

The University must certify that it is not delinquent on the repayment of any federal debt before an award can be made. In addition, PIs are individually required to certify that they are neither debarred nor suspended from doing business with the federal government. Affirmation is made by completing and signing the OSP Synopsis form. Affirmation of nondebarment and nonsuspension for the principals of the University is made by the signature of the University's authorizing official.

Drug-free Workplace

The University is required by federal regulation to maintain both a drug-free workplace and formal drug and alcohol abuse prevention programs. The Policies on Substance Abuse and Alcoholic Beverages distributed regularly by the Personnel Services Division identify the programs and resources available to NYU faculty, staff and students, and describe institutional standards of conduct, the health risks associated with substance abuse, and criminal and institutional sanctions for violations. Applicants for individual fellowships must also certify that, as a condition of award, they will not engage in unlawful actions involving a controlled substance in conducting any funded activity.

Lobbying

Federal rules prohibit the use of federal funds to influence officials of Congress and Executive Branch agencies in connection with a specific award. University funds may be used for such activities; however, any lobbying by individuals other than regularly employed staff must be disclosed to the agency in writing. All such lobbying must be coordinated through the Office of Government and Community Relations. Where disclosure is required in connection with a specific proposal, OSP will file the disclosure material with relevant federal authorities.

Misconduct in Science

Several federal agencies require applicant organizations to certify that the institution has established appropriate administrative policies for dealing with and reporting possible scientific misconduct. NYU's policy was approved by the Board of Trustees on December 8, 1986. Consult OSP for the date of its annual filing with the Department of Health and Human Services (DHHS) when required on application forms.

Conflict of Interest

Some Federal sponsors, such as the National Institutes of Health (NIH) and the National Science Foundation (NSF), require applicant organizations to certify that the institution has written and enforced administrative policies for identifying, managing, and reporting the significant outside financial interests of key project staff. In accordance with NYU Policy on Academic Conflict of Interest and Conflict of Commitment, effective July 1, 2011, the PI, and all other Investigators, must file with the dean, at the time of proposal submission, an Investigator Financial Interest Disclosure indicating whether they, or any member of their families, has a financial interest in an outside entity that may be affected by, or may in turn affect, the proposed project, and if so, to disclose that interest to the dean for his or her review and approval.

With most proposals, sponsors also require the University to certify that it has on file an assurance of compliance, or will comply, with various federal, state or local nondiscrimination statutes.

Inventions and Patents

Federal patent law requires that all employees file with the University an agreement that they will report any inventions made during the course of a federally funded project and assign rights to the institution. OSP will provide the PI with a form Agreement to Disclose, which was developed for this purpose, at the time of proposal submission. Direct any questions regarding management of the University's patent and licensing program to the Office for Industrial Liaison, 550 First Avenue,Room 153, telephone 263-8191.